Medicare Part D plan sponsors may appeal program integrity prescription drug event record review audit determinations.

1. (a) Issues eligible for appeal.

   1. (1) CMS's application of Part D policy(ies).
   2. (2) Factual or data errors.

2. (b) Issues ineligible for appeal.

   1. (1) The Part D plan sponsor's failure to submit documentation in the timeframes specified by CMS during the audit.
   2. (2) The program integrity prescription drug event record review audit methodology.

[91 FR 17594, Apr. 6, 2026]